BackgroundWe evaluated the analytical performance of the fully automated cobas® 6500 urine work area and its automated components—cobas u 601 and cobas u 701.Design and methodsThe study was conducted at three European centers using un-centrifuged surplus routine urine samples; all measurements were performed within 2 h of sample collection. Precision, sample carry-over, and method comparisons were evaluated per Clinical and Laboratory Standards Institute guidelines. Method comparisons: cobas u 601 versus Urisys 2400 and cobas u 411 urine test strips; and cobas u 701 versus KOVA® visual microscopy and iQ200 analyzer. Operability and functionality were assessed using questionnaires.ResultsPrecision of the entire cobas 6500 system was within predefined acceptance limits and no significant carry-over was observed. Erythrocytes, leukocytes, nitrites, and protein were in good agreement (≥93%) with cobas u 411 reflectometry. High correlation was shown between the cobas u 701 analyzer and KOVA visual microscopy for red blood cells (RBC; slope, 0.89; Pearson’s r, 0.95) and white blood cells (WBC; slope, 0.96; Pearson’s r, 0.96), demonstrating equivalence of test results. The 97.5% percentile reference values on the cobas u 701 analyzer were 5.3 cells/μL (RBC) and 6.2 cells/μL (WBC). The cobas 6500 system showed good sensitivity for small bacteria (>1 μm) and pathological casts, and the user interface, maintenance wizards, and system design were highly rated by operators.ConclusionsThe fully automated workflow, high precision, and high throughput of the cobas 6500 system have the potential to facilitate standardization of urine screening.

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Objectives To assess the impact of the COVID-19 pandemic on the activity of clinical laboratories in Spain. Methods A descriptive, observational, retrospective, multicenter study. Results Between March and December 2020, there was a statistically significant decrease in the number of test requests (−17.7%, p=<0.001) and total tests performed (−18.3%, p<0.001) with respect to the same period in 2019. A decrease was observed in the number of requests from primary care (−37.4%) (p<0.001) and in the number of foecal occult blood (−45.8%); qualitative urine (−30.1%); PSA (−28.5%); TSH (−27.8%); total cholesterol (−27.2%) and HbA1c (−24.7%) tests performed, p<0.001. A significant increase was found in the number of requests from ICUs (76.6%, p<0.001) and number of IL-6 (+22,350.9), D-dimer (+617.2%), troponin (+46.8%) and arterial blood gas (+3.9%) tests carried out, p<0.001. During the first months of 2021, there were significant changes in the number of requests for qualitative urine (−8.7%, p<0.001), PSA (−6.3%, p=0.009), IL-6 (+66,269.2, p<0.001), D-dimer (+603.6%, p<0.001), troponin (+28.7%, p<0.001), arterial blood gas (+26,2%, p=0.014) and ferritin (+16.0%, p=0.002) tests performed. Conclusions There were changes in the origin and number of test requested to clinical laboratories in Spain. The number of requests for the evaluation and monitoring of COVID-19 patients increased, whereas requests for the control of non-COVID patients and for population screening decreased. Long-term analysis reveals that the volume of tests performed for the control of chronic diseases returned to normal over time, whereas the increase observed in the volume of tests performed for the management of COVID-19 patients is maintained.

Resumen Objetivos Cuantificar el impacto de la pandemia en la actividad asistencial de los laboratorios clínicos españoles. Métodos Estudio descriptivo, observacional, retrospectivo y multicéntrico. Resultados De marzo a diciembre de 2020 hubo un descenso estadísticamente significativo en el número de solicitudes (−17.7%, p=<0,001) y análisis totales (−18,3%, p<0,001) respecto al mismo periodo de 2019. Se redujo el número de solicitudes de Atención Primaria en un 37,4% (p<0,001) y el número de mediciones de sangre oculta en heces (−45,8%), análisis cualitativo de orina (−30,1%), antígeno prostático específico (PSA) (−28,5%), tirotropina (TSH) (−27,8%), colesterol total (−27,2%) y hemoglobina glicosilada (HbA1c) (−24,7%), p<0,001. Se observó un aumento significativo del número de solicitudes de UCI (76,6%, p<0,001) y del número de mediciones de IL-6 (+22,350,9), dímero-D (+617,2%), troponina (+46,8%) y gasometría arterial (+35,9%), p<0,001. Durante los seis primeros meses de 2021, existieron diferencias significativas para análisis cualitativo de orina (−8,7%, p<0,001), PSA (−6,3%, p=0,009), IL-6 (+66.269,2, p<0,001), dímero-D (+603,6%, p<0,001), troponina (+28,7%, p<0,001), gasometría arterial (+26,2%, p=0,014) y ferritina (+16,0%, p=0,002). Conclusiones Los laboratorios clínicos españoles han sufrido un cambio en el origen de sus solicitudes y en la demanda de pruebas. Se han incrementado aquellas utilizadas en la evaluación y seguimiento de los pacientes COVID-19, y han disminuido las dirigidas al control de los pacientes no-COVID y a cribados poblacionales. El análisis a más largo plazo refleja una recuperación en las pruebas dirigidas al control de las enfermedades crónicas y se mantiene el aumento del número de mediciones de los biomarcadores utilizados en el manejo de los pacientes COVID-19.

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